FDA Not Getting Data on Risky Drugs; Federal Watchdog Says Makers Largely Ignore High-Risk Safety Requirements; BUSINESS

Article excerpt

WASHINGTON The Food and Drug Administration is not receiving key information from drugmakers about whether some of the riskiest prescription drugs on the market are being used safely by doctors and patients, according a new report by government inspectors.

The reports findings suggest that pharmaceutical companies have largely ignored recent federal requirements designed to manage the safety of high-risk medications. That means American patients could be at greater risk of injury from dozens of drugs with serious side effects, ranging from birth defects to blindness.

The report from the Department Health and Human Services Office of Inspector General is the first independent review of a five-year- old program designed to give the FDA more control over prescription drugs.

Beginning in 2008, the FDA gained the power to require manufacturers to develop risk-management plans for new drugs. The plans, known as Risk Evaluation and Mitigation Strategies, or REMS, can include a range of requirements:

Patient brochures warning about drug side effects.

Specialized training for doctors who prescribe some drugs.

Limited distribution of drugs by certain hospitals or pharmacies.

But when federal HHS inspectors reviewed the FDAs assessments of these plans, they found that the majority were apparently not meeting their goals of improving patient safety, according to the report released Wednesday. Examples of goals for the plans include preventing drug exposure in pregnant women and educating doctors and patients about safety risks.

Only seven out of the 49 REMS plans reviewed by inspectors were meeting all their goals, according to the report.

Among 19 plans for the riskiest drugs which have requirements such as special doctor training or limited distribution only one was meeting all of its goals. …


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